Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )

Phase

N/A

Condition

Epilepsy

Treatment

SOFT ECoG subdural grid electrode

Clinical Study ID

NCT06205160

CIP-01202

Ages > 18
All Genders

Study Summary

The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics SA (test device; TD), in comparison to regular high-density electrode grids (ADTech, CE-marked) (control device; CD) routinely used at the investigation site during epilepsy surgery.

Subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the TD next to the standard recordings with the CD during ECoG-tailored epilepsy surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age ≥18 years at the time of enrolment
Lesional epilepsy (incl. secondary mesial temporal sclerosis) that is considered acandidate for intra-operative high-density grid recordings (incl. patients whounderwent sEEG preceding resective surgery)
Provided informed consent for study participation by the subject

Exclusion

Exclusion Criteria:

Occipital lesion
Surgeries involving a primary mesial temporal lesion, a disconnection, orhemispherectomy.
Planned ioECoG recordings during fully awake surgery and/or functional recordings
Use of anticoagulants that cannot be discontinued during the perioperative period,or a factor XIII deficiency or any other haematological disease
Active participation in another investigational device study
Any other condition that in the opinion of the investigator may adversely affect thesafety of the subject or would limit the subject's ability to complete the study.
Insufficient understanding of Dutch language.

Study Design